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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMBU INC. 4900320000-2017-8036 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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AMBU INC. 4900320000-2017-8036 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2017
Event Type  malfunction  
Event Description
Ambu bag not performing correctly - all connections and lines secure and cross checked.
 
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Brand Name4900320000-2017-8036
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
AMBU INC.
6230 old dobbin ln.
ste. 250
columbia MD 21045
MDR Report Key6739960
MDR Text Key80915604
Report Number6739960
Device Sequence Number0
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2017
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/09/2017
Event Location Hospital
Date Report to Manufacturer07/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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